Kornimate/medical-research-clean huggingface dataset:
coronally advanced flap with or without porcine collagen matrix for root coverage

Conditions: Gingival Recession

Summary: the purpose of this study is to compare the clinical outcomes after coronally advanced flap technique (caf) associated or not to a porcine collagen matrix graft (cm) in the treatment of single gingival recessions. for this blinded randomized controlled clinical trial, 40 patients with miller class i or ii gingival recession ≥ 2 mm in canines or premolars will selected and randomly assigned to receive either caf or caf+cm. the clinical parameters evaluated will be probing depth, clinical attachment level, gingival recession height, height and thickness of keratinized tissue. clinical measurements will be taken at baseline and 45 days, 2, 3 and 6 months after surgery.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * presence of at least one class i or ii miller gingival recession ≥ 2 mm in maxillary canines or premolars with identifiable cementum-enamel junction (cej) and without deep non-carious cervical lesions (\< 0.5 mm): a + (pini-prato et al. 2010). * aesthetic complaint and/or presence of dentin hypersensitivity to air stimulus. * full-mouth visible plaque index ≤ 20% (ainamo \& bay 1975). * full-mouth sulcus bleeding index ≤ 20% (mühlemann \& son 1971). exclusion criteria: * smoking. * pregnancy. * presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery). * use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair). * previous periodontal surgery in the area.

Keywords: gingival recession/surgery collagen/therapeutic use root coverage treatment outcome
managing asthma patients with amaze™: a novel disease management platform

Conditions: Asthma

Summary: the primary study objective is to generate evidence as to the feasibility, usability, perceived value, and potential benefits of implementing the amaze™ platform into clinical practice.

astrazeneca has developed the amaze™ disease management platform to be used across multiple disease indications to provide a unified experience for the management of participants throughout their participant care journey. amaze™ integrates multiple systems, including a patient mobile application where patients can enter daily symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials. implementation of amaze™ within clinical practice has not yet been evaluated. the results from this study will be used to inform any changes or modifications that need to be made to the technology platform, its implementation process, and explore impact on clinical outcomes.

Eligibility criteria:
inclusion criteria: * \>18 years of age at the time of enrollment * clinically confirmed diagnosis of asthma * access to a smartphone with internet access with the following requirements: ios (operating system ios 13 or newer and devices iphone 8 or newer) or android (operating system 8.0 or newer) * able to understand and speak english sufficiently to be able to use the amaze™ patient app * willingness to participate in a telephone interview and be audio-recorded * consenting to participate in the study exclusion criteria: * current diagnosis of active chronic obstructive pulmonary disease (copd) or any pulmonary diagnosis other than asthma * has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the english language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the act™.
collection of blood specimens for circulating tumor cell analysis

Conditions: Breast Cancer; Prostate Cancer; Colorectal Cancer

Summary: objective: to test the sensitivity of a proprietary novel filtration device designed to capture and concentrate circulating tumor cells (ctcs).


Eligibility criteria:
inclusion criteria: * age \> 18 years of age * written informed consent obtained * confirmed diagnosis of stage 2-4 breast, prostate, or colorectal cancer, (or) no prior history of cancer * stage 2-4 treatment naive, metastatic, secondary, and recurrent cancer patients * able to undergo blood collection prior to initiation of chemotherapy treatment, (or) able to provide blood sample if subject is a non-cancer control subject exclusion criteria: * patients unable to understand the research protocol and/or provide informed consent. * patients with known immunodeficiency, or pregnancy.

Keywords: breast cancer prostate cancer colorectal cancer circulating tumor cell (ctc)
intravitreal lfg316 in patients with age-related macular degeneration (amd)

Conditions: Geographic Atrophy; Age-related Macular Degeneration

Summary: this study was conducted in two parts; part a and part b: part b was initially planned to include two cohorts. cohort 2 was cancelled following an interim analysis for efficacy in part a of the study, and not due to any safety issues or concerns. cohort 2 is not referred to again and part b cohort 1 is referred to as part b alone in the remainder of the document and is the subject of this report. part b was conducted to assess the safety and tolerability of a single intravitreal (ivt) lfg316 10 mg/100 µl injection. there was no efficacy evaluation in part b. the study employed a multicenter, randomized, sham - controlled, single masked design. eight patients with advanced amd were planned to be randomized in a 3:1 ratio to receive a single ivt dose of lfg316 (10 mg/100 µl) or sham injection. patients assigned to a sham injection were treated the same as those assigned to lfg316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the ivt injection.


Eligibility criteria:
inclusion criteria: * diagnosis of amd if enrolled in part b of study * geographic atrophy in at least one eye if enrolled in part a of study * etdrs best corrected visual acuity of 60 letters or worse (\~≤ 20/63) exclusion criteria: * retinal disease other than amd * history of choroidal neovascularization * severe cataract * history of infectious uveitis or endophthalmitis * eye surgery in the non-study eye within 30 days prior to study * eye surgery or ivt injection in the study eye within 90 days prior to study * other protocol-defined inclusion/exclusion criteria may apply

Keywords: amd age-related macular degeneration geographic atrophy ga dry amd blindness drusen ga lesion
eyelid androgen treatment in dry eye

Conditions: Aqueous Tear Deficiency; Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)

Summary: the purpose of this research study is to evaluate the effectiveness and safety of applying androgen sex hormone (i.e., testosterone) gel on the eyelids in the treatment of dry eye patients. several studies have demonstrated positive treatment effects in dry eye, but few have applied testosterone gels to the eyelids.

the purpose of this study is to examine the safety and efficacy of transdermal eyelid application of testosterone gel along with the length of any beneficial effect following cessation of treatment. moderate to severe dry eye subjects will be enrolled into a randomized controlled trial with assignment to either an \~ 4.5% fda-approved androgen gel (natesto®, acerus pharmaceuticals, mississagua, canada) or a placebo formulated similar to natesto® without testosterone. the gel will be applied to both eyelids in the morning and 12 hours later on both eyelids for a 30 day treatment period subjects will fulfil dews ii criteria for eligibility and further be classified as moderate or severe based on dews ii recommendations. a standardized examination involving signs and symptoms of dry eye and monitoring function of the meibomian and lacrimal glands, as well as clinical tear and ocular surface measures, iop, and serum testosterone levels, at baseline, following 30 days of testosterone application, and at one and two months post-treatment.

Eligibility criteria:
inclusion criteria: * moderate to severe dry eye (tbut \ grade 1.5, evidence of meibomian gland secretion compromise or schirmer \< 5 mm wetting in 5 minutes) * age over 18 * mild ectropion * previous contact lens wearers if no wear for prior 6 months * punctal plugs if more than three months since placement * systemic tetracyclines, antihistamines if consistent dosing * sjogren's syndrome and related autoimmune conditions can be enrolled * patients using topical dry eye treatments (e.g., restasis) if willing to discontinue for 30 days exclusion criteria: * if artificial tears or autologous serum used on day of study * ocular surgery if less than 12 months * punctal plugs if within 3 months of plug insertion * contact lens wear within the six months prior to study * psa levels greater than 4 ng/ml or bph * recent or current thrombolism * recent or current cardiovascular events (e.g., mi, stroke) * recent or current liver disorders * concurrent use of topical medications; e,g., topical glaucoma medications * diabetics * females of child-bearing age if not on reliable birth control * history of breast cancer * cannot be taking insulin, warfarin or systemic corticosteroids

Keywords: testosterone fluorescein breakup time androgen dry eye
effect of pentoxifylline on preventing chemotherapy-induced toxicities in patients with breast cancer

Conditions: Breast Cancer Female; Breast Cancer Patients; Neoadjuvant Therapy; Doxorubicin; Taxane-induced Peripheral Neuropathy

Summary: this clinical trial is a randomized clinical trial that aims to assess the usefulness of adding pentoxifylline to the neoadjuvant chemotherapy treatment protocol of doxorubicin/cyclophosphamide fllowed by taxane for breast cancer patients to decrease the incidence of developing toxicities, and enhance the quality of patient life using the eq-5d-3l questionnaire. the participant will administer pentoxifylline oral tablets three times per day along with the treatment protocol, starting from the first doxorubicin/cyclophosphamide cycle till the end of the chemotherapy cycles. the researchers will compare the incidence and grade of mucosities, neuropathy, and other chemotherapy-related toxicities in the presence or absence of oral pentoxifylline.


Eligibility criteria:
inclusion criteria: 1. adult female patients \>18 years old with histologic confirmation of invasive breast cancer 2. planned to administer neoadjuvant chemotherapy protocol comprised of doxorubicin/ cyclophosphamide followed by paclitaxel (ac/t) 3. adequate hepatic, renal, and bone marrow functions exclusion criteria: 1. patients on a treatment regimen of phosphodiesterase inhibitors 2. patients who are taking antiplatelet or anticoagulant treatment 3. patients who are allergic to phosphodiesterase inhibitors 4. history of recent hemorrhagic events 5. active peptic ulcer 6. patients who have mouth or teeth problem.

Keywords: neoadjuvant chemotherapy, pentoxiphyllin, doxorubicin, cyclophosphamide, mucositis, quality of life
comparative efficacy study of action observation therapy and mirror therapy after stroke

Conditions: Stroke

Summary: the specific aims of this study will be to: 1. investigate the treatment efficacy of action observation therapy (aot), mirror therapy (mt) versus a control intervention on motor and functional outcomes of stroke patients. 2. compare the mechanisms and changes in cortical neural activity after aot, mt, and control intervention by using magnetoencephalography (meg). 3. determine the correlations between neural activation changes and clinical outcomes after aot and mt. 4. identify who are the potential good responders to aot and mt.

in this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of aot, mt versus a control intervention on motor and functional outcomes of stroke patients, (2) compare the mechanisms and changes in cortical neural activity after aot, mt, and control intervention by using magnetoencephalography (meg), (3) determine the correlations between neural activation changes and clinical outcomes after aot and mt, and (4) identify who are the potential good responders to aot and mt. an estimated total of 90 patients with subacute stroke will be recruited in this study. all participants will be randomly assigned to receive aot, mt, or control intervention for a 3-week training period (a total of 15 sessions). outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. for the meg study, the investigators anticipate to recruit 12 to 15 patients in each group. the patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the meg eligibility criteria or are not willing to participate in the meg study.

Eligibility criteria:
inclusion criteria: 1. diagnosed as having a unilateral stroke 2. 1 to 6 months after stroke onset 3. from 20 to 80 years of age 4. a baseline score of the fugl-meyer assessment (fma) of 20 to 60 5. able to follow the study instructions (measured by the montreal cognitive assessment) 6. capable of participating in therapy and assessment sessions exclusion criteria: 1. patients with global or receptive aphasia 2. severe neglect 3. major medical problems, or comorbidities that influenced ue usage or caused severe pain

Keywords: stroke translational rehabilitation mirror neuron system action observation mirror therapy meg
the effects of treatment with sertraline for noncardiac chest pain

Conditions: Panic Attacks; Chest Pain; Depression

Summary: the purpose of this study is to determine whether care as usual or intervention (consisting of sertraline versus placebo), are effective in the treatment of panic disorder and/or depression driven noncardiac chest pain.

noncardiac chest pain remains an important problem in clinical cardiology. often, panic disorder and/or depression are the underlying cause. however, this is largely underdiagnosed. there are no clear existing treatment strategies/methods for this specific patient population. in our double blind, placebo controlled care as usual versus sertraline study, we want to investigate whether intervention is more effective as care as usual for diminishing chest pain, and also if sertraline is more effective in this specific population compared to placebo.

Eligibility criteria:
inclusion criteria: * chest pain without a cardiac cause * diagnosed with panic disorder and or depression according to diagnostic and statistical manual (dsm) iv criteria * living \< 50 km from the hospital * informed consent exclusion criteria: * other primary dsm iv diagnosis * known sensitivity to sertraline * using other anti-depressive agents * not speaking dutch language * living in a nursery home or having dementia * other severe, acute or progressive disease, kidney or liver-function disturbances, pregnancy or breastfeeding

Keywords: chest pain panic attacks palpitations depression panic disorder depressive disorder non cardiac chest pain
detection of helicobacter pylori in ulcerative colitis patients

Conditions: Inflammatory Bowel Diseases

Summary: helicobacter pylori (h. pylori) infection is one of the most common infectious diseases in humans.

several bacterial and viral agents may have a role in the aetiology of ibd. in theory, h. pylori infection could be involved in ibd by inducing alterations in gastric and/or intestinal permeability or by causing immunological derangements resulting in absorption of antigenic material and autoimmunity via various immunological pathways.

Eligibility criteria:
inclusion criteria: * newly diagnosed ulcerative colitis exclusion criteria: * other diagnosis
improving the medication management of patients with attention-deficit hyperactivity disorder

Conditions: Attention Deficit-hyperactivity Disorder

Summary: the specific aim of this cluster-randomized (site) comparative effectiveness research study is to determine whether children who are (1) 5-12 years of age, (2) cared for in epros practices or clinics using an electronic health record (ehr), (3) have attention-deficit hyperactivity disorder (adhd), and (4) are to receive treatment with stimulant medication for the first time in these practices, have superior clinical outcomes if their clinicians have access to an ehr-guided clinical decision support system (intervention group) than if their clinicians have no such access (control group).

in this cluster (site)-randomized trial of clinical decision support for adhd medication titration, clinicians caring for children with adhd whose families are initiating stimulant medication at that practice will be followed. two groups will be compared; an intervention group, which will receive the intervention-the clinical decision support (cds)--, and a control group, who will not receive cds. over a 6-month period, the cds will support guideline-based medication titration to achieve optimal symptom control with minimal side effects. the study will track the care delivered to affected children by the practitioners and will assess the endpoints of symptom reduction and side effects. there will also be a sub-study within the larger study which will give the team a better understanding about the pros and cons of consenting parents over the phone.

Eligibility criteria:
practice eligibility criteria * willing to offer the possibility of study enrollment to their patients who have adhd * willing to use the vanderbilt assessment rating scale to assess and potentially, to monitor adhd for study subjects * utilize integrated health connect as a means to collect the vanderbilt assessment rating scale * use point-of-care reports for subjects enrolled in the study. patient eligibility criteria * the child must be between the ages of 5-12 years old * the child must be starting stimulant medication for the first time * parent must be able to speak and read english * the child must not be diagnosed with a current manic episode, a psychotic disorder, or a pervasive developmental disorder (e.g. autism, asperger's, rett's disorder) * the child must not have reported suicidality or have conduct disorder, per parent/guardian report

Keywords: clinical decision support electronic health records electronic medical records attention deficit-hyperactivity disorder primary care pediatric research network
a genotype stratification study for pharmacokinetics and pharmacodynamics of amitriptyline in healthy male subjects

Conditions: Depression

Summary: a total of 24 healthy korean male subjects will receive a single oral dose of amitriptyline, 25 mg. subjects will be enrolled in this study based on their cytochrome p450 2d6 and cytochrome p450 2c19 genotypes, and serial blood sampling will be done for plasma concentrations of amitriptyline, nortriptyline, and their metabolites. various pharmacodynamic markers related to the adverse event of amitriptyline will be measured serially during the study.


Eligibility criteria:
inclusion criteria: * healthy male volunteer, age 19\~45 years * the result of body mass index(bmi) is not less than 19 kg/m2 , no more than 28 kg/m2 * subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. * voluntarily signed the informed consent form exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study * history of relevant drug allergies or clinically significant hypersensitivity reaction. * smoked more than 10 cigarettes a day for past 3 months * not eligible due to other reasons including laboratory results

Keywords: amitriptyline cyp2d6 cyp2c19
an in-home study of brain computer interfaces

Conditions: Amyotrophic Lateral Sclerosis

Summary: the investigators are developing a tool to help people who are severely paralyzed. this tool is called a brain-computer interface (bci). bcis can connect to computers or other electronic devices. this study allows a person with als to communicate, control their wheelchair tilt and perform other tasks using a bci, thus increasing their independence.

this small-scale study of the feasibility of a bci to operate the tilt position of a power wheelchair was also designed to determine the conditions and support structures necessary for use of a bci in the home. in this study, people with amyotrophic lateral sclerosis (als) will have a bci in their home. they will receive training in order to operate and maintain the bci. the bci will allow them to access at least one task of primary interest to them. task may include communication, computer access, control of assistive technology, or control of wheelchair seat position. data concerning the use of the bci will be collected throughout the study. custom installations will be made for each participant to connect to their wheelchair and provide communication options if needed. each installation is expected to be a unique prototype because of the differing control requirements for the individual wheelchairs in use by the participants. we intended to enroll six participants, but were only able to enroll one.

Eligibility criteria:
inclusion criteria: * age 18 or older. * presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months. * able to see the bci display * able to understand and remember instructions concerning participation. * live in an environment that can accommodate the wheelchair portable bci host computer * expected to live in the same physical environment for at least 6 months. * has family and caregiver(s) who are supportive of participation in this research. * has a primary caregiver who is technically capable, willing to learn the setup and operation of the bci system, and likely to remain with the subject for at least 6 months. * has been shown to be able to use a bci (in an experimental session under another irb, e.g. hum 00012968). * has a clear understanding of the shortcomings of the present state of bci technology exclusion criteria: * open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes. * inability to communicate well enough to give informed consent. * history of photo-sensitive epilepsy * known significant cognitive deficits
the skin microbiome in graft versus host disease

Conditions: Skin Microbiome; Graft Versus Host Disease; Graft Versus Host Disease in Skin

Summary: based on the evidence on the impact of the intestinal microbiome on the graft versus host disease (gvhd) after allogeneic hematopoietic stem cell transplantation (allo-hsct), it is hypothesized that the skin-microbiome may play a role in cutaneous gvhd as well. therefore, this study aims at investigating the skin-microbiota of patients with gvhd after allo-hsct and of patients without gvhd after allo-hsct.


Eligibility criteria:
inclusion criteria: * undergoing allo-hsct at the university hospital basel exclusion criteria: * missing ability to judge * illiteracy or lack of german, french or english language

Keywords: allogeneic hematopoietic stem cell transplantation